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Singapore HSA registration DE0502744

GE NM/CT 850 Imaging System

Singapore flagSingapore·CLASS C·GE Medical Systems Israel, Functional Imaging·Registered January 30, 2019
Device classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration information
Registration Number
DE0502744
Registration Date
January 30, 2019
Change Notification Approval Date
June 03, 2019
Retention Due Date
January 29, 2026
Product description
The GE NM/CT 850 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography component which is intended specifically for enabling attenuation correction and anatomical localization of SPECT images. The GE NM/CT 850 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in the assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors; and planning, guiding, and monitoring therapy.
Product Owner
Name
GE Medical Systems Israel, Functional Imaging
Short Name
GE Medical Systems Israel, Functional Imaging
Address
4 Hayozma Street, Tirat Hacarmel, 30200 ISRAEL, ISRAEL
Registrant
Name
GE HEALTHCARE PTE. LTD.
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Importer
Name
GE HEALTHCARE PTE. LTD.
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Model information
Model Name(s)
Integrated ECG NM/CT 850 NM/CT 850
Model Identifier(s)
H2506KR H3907AF H3907AG
About this record

Access comprehensive regulatory information for GE NM/CT 850 Imaging System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0502744 and owned by GE Medical Systems Israel, Functional Imaging. The device was registered on January 30, 2019.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS C